Labeler · US market

Azurity Pharmaceuticals, Inc.

Azurity Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 37 drug concepts (35 currently active) across 77 packages. It is currently the only active US supplier of 15 drugs. The company files with FDA under 3 name variants, merged into this profile.

Also files as: Azurity Pharmaceutcials, Inc. · Azurity Pharmaceuticals

ACTIVE — US

openFDA · updated weekly

Labeler codes24338 · 52652 · 60631 · 65628

Active drugs35

Registrations59 active / 61

Packages77

Sole supplier of15 drugs

Portfolio37 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Dextroamphetamine Sulfate tablet	rx	7	7	SUPPLYING
Lisdexamfetamine Dimesylate Oral solution	rx	5	5	SUPPLYING
Azilsartan Kamedoxomil tablet	rx	2	4	SUPPLYING
Vancomycin Hydrochloride kit	rx	4	4	SUPPLYING
Nimodipine solution	rx	2	4	SUPPLYING
Omeprazole And Sodium Bicarbonate kit	rx	1	3	SUPPLYING
Lomustine capsule, gelatin coated	rx	3	3	SUPPLYING
Telmisartan, Amlodipine And Indapamide tablet	rx	3	3	SUPPLYING
Topiramate solution	rx	1	3	SUPPLYING
Lansoprazole kit	other	1	3	SUPPLYING
Amphetamine Sulfate tablet	rx	2	2	SUPPLYING
Sotalol Hydrochloride solution	rx	1	2	SUPPLYING
Testosterone Cypionate injection, solution	rx	2	2	SUPPLYING
Nilotinib tablet	rx	2	2	SUPPLYING
Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate solution, concentrate	rx	2	2	SUPPLYING
Methotrexate solution	rx	1	2	SUPPLYING
Diphenhydramine Hydrochloride And Lidocaine Hydrochloride And Aluminum Hydroxide And Magnesium Hydro kit	other	1	2	SUPPLYING
Ferumoxytol injection	rx	2	2	SUPPLYING
Baclofen suspension	rx	1	2	SUPPLYING
Amlodipine suspension	rx	1	1	SUPPLYING
Bendamustine Hydrochloride injection	rx	1	1	SUPPLYING
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride powder, for solution	rx	1	1	SUPPLYING
Hydralazine Hydrochloride And Isosorbide Dinitrate tablet, film coated	rx	1	1	SUPPLYING
Meloxicam injection	rx	1	1	SUPPLYING
Ivermectin lotion	otc	1	1	SUPPLYING
Triptorelin kit	rx	1	1	SUPPLYING
Sitagliptin Hydrochloride Oral solution	rx	1	1	SUPPLYING
Carmustine wafer	rx	1	1	SUPPLYING
Enalapril Maleate solution	rx	1	1	SUPPLYING
Mycophenolate Mofetil suspension	rx	1	1	SUPPLYING
Zonisamide suspension	rx	1	1	SUPPLYING
Clonidine Hydrochloride Oral solution	rx	1	1	SUPPLYING
Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, And Sodium Chloride For Oral Solution kit	rx	1	1	SUPPLYING
Sodium Sulfate, Magnesium Sulfate, And Potassium Chloride tablet	rx	1	1	SUPPLYING
Lisinopril solution	rx	1	1	SUPPLYING
Omeprazole kit	other	1	3	DISCONTINUED
Metronidazole Benzoate kit	other	1	1	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+5 more

At a glance

TypeLabeler
Labeler codes24338, 52652, 60631, 65628
Filing names3
Drugs (active)35
Drugs (all time)37
US registrations61
Packages77

Recent events

Shortages, recalls, and registration changes across all filing names.

Jan 4, 2024
RECALLRecall (Class I): Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals,…
Dec 8, 2023
RECALLRecall (Class III): Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Wobur…
Feb 15, 2023
RECALLRecall (Class II): Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) an…
Aug 24, 2021
RECALLRecall (Class I): Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7…
Apr 10, 2020
SHORTAGEDrug shortage: Dexmedetomidine Hydrochloride Injection (Azurity Pharmaceuticals, Inc)

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.